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last updated: 2026-03-05 by BA
file_name: CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020).md
file_date: 2020-12-28
title: CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020)
category: regulatory
subcategory: surveillance
tags:
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notes:
summary_short: The CMS CLIA Surveillance Testing notice (Dec. 28, 2020) explains when a facility is considered a CLIA-regulated laboratory and states that COVID-19 testing generally requires CLIA certification if patient-specific results are reported. It describes CMS’s temporary enforcement discretion for SARS-CoV-2 surveillance testing in non-CLIA facilities, allowing non-FDA-authorized methods so long as no individual results (e.g., negative/positive/inconclusive) are provided and individuals are only referred to CLIA-certified labs for follow-up.


CONTENT

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
Division of Clinical Laboratory Improvement & Quality
Northeastern and Midwestern Operations Branch
Chicago Office
233 North Michigan Avenue, Suite 600
Chicago, IL 60601-551

Sent via email to:
IMPORTANT NOTICE – PLEASE READ CAREFULLY

December 28, 2020
\[Recipient Redacted\]
RE: CLIA SURVEILLANCE TESTING

\[Recipient Redacted\],
It has come to our attention that your facility \[Recipient Redacted\], is performing COVID-19 testing. In order to conduct COVID-19 testing, a facility must be a CLIA certified laboratory that meets applicable regulatory requirements appropriate for the complexity designation of the test. A CLIA certificate is required for any testing facility that meets the CLIA regulatory definition of a laboratory. The CLIA regulations at 42 CFR Part 493 define a laboratory as “a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body.

To become CLIA-certified, laboratories must comply with the accuracy, quality, and reliability requirements as dictated by the statute. The purpose of these requirements is to ensure that the information that patients or their health care providers receive from a clinical laboratory is accurate and reliable test results. Laboratories that wish to become CLIA certified must apply for a CLIA

Certificate. You may access the CLIA regulations at: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

If you elect to apply for CLIA certificate, a CLIA application may be obtained from:
\[State Public Health Department\]

Generally, SARS-CoV-2 surveillance testing can be performed in a facility that is NOT CLIA

certified, and may use a test or technique NOT authorized by the FDA, provided that patient-specific results are not reported. If at any time a patient-specific result is reported, the facility is subject to CLIA and required to obtain an appropriate CLIA certificate in accordance with 42 CFR part 493.

CMS is temporarily exercising enforcement discretion under CLIA for SARS-CoV-2 surveillance testing, specifically, neither CMS nor the State survey agencies on its behalf will cite non-CLIA certified facilities, provided that the facility does not report actual test results, but only refers an individual to a CLIA-certified laboratory for further testing. No individuals can be given a patient-specific result from any testing, that is from a sample that is negative, positive, inconclusive, presumptive positive, a result of clinical significance, or a result of potential clinical significance. If at any time a patient specific result is to be reported by a facility, a CLIA certificate must be obtained, and the facility must meet all requirements to perform testing. You may contact Raymond Castillo via electronic mail at: raymond.castillo@cms.hhs.gov should you have additional questions.

Sincerely,

Ronisha Blackstone, Manager
Division of Clinical Laboratory Improvement & Quality
Northeastern and Midwestern Operations Branch
(Chicago, Boston, New York and Philadelphia)

cc: IDPH